- The prescription oral contraceptive, Tydemy, may be less effective due to a decreased amount of ascorbic acid in two lots distributed from June 3, 2022 to May 31, 2023, according to a recent announcement from the FDA.
- Lupin Pharmaceuticals, the manufacturer of the product, advise patients to keep taking their medication but to speak with their physician about alternative types of contraception.
- While there have been no reports of adverse events to date, experts recommend patients who are concerned should use other contraceptive methods.
The FDA recently announced that the birth control pill, Tydemy, could be less effective as a result of a decreased amount of ascorbic acid in two lots distributed from June 3, 2022 to May 31, 2023.
This prescription oral contraceptive was manufactured by Lupin Pharmaceuticals. The company recalled the two lots of Tydemy, L200183 and L201560, warning that unexpected pregnancy may occur due to the pill’s lack of effectiveness.
Lupin recommends patients keep taking their medication, but to consult with their primary care physician about another form of contraception.
Experts’ advice for people taking Tydemy birth control pills
“In this case, the active ingredients for protecting against pregnancy are really estrogen and progestin, and the announcement doesn’t say anything about low levels of the active ingredients, just ascorbic acid which is an inactive ingredient,” Tessa Madden, MD, a Professor of Medicine and Section Chief of Family Planning at Yale School of Medicine, told Healthline. “So it’s not clear how much impact that would have on effectiveness.”
That being said, if patients are concerned about decreased effectiveness they certainly could talk to their healthcare provider about switching to a different oral contraceptive pill, Madden added.
“They do say they haven’t had reports of pregnancy, which is good,” noted Pamela Berens, MD, professor and OBGYN with UTHealth Houston.
Additional side effects from recalled Tydemy pills
It’s important to be aware of the risks of taking birth control pills with potentially reduced effectiveness.
“Beyond pregnancy, which is the obvious risk, I would expect the other possible risk might be irregular bleeding,” said Berens.
Checking the expiration date on medication, including birth control, is also recommended.
“In general, the primary issue with taking medications past their expiration date is decreased effectiveness, so unexpected pregnancies would be the biggest concern,” Madden stated. “That said, the expiration date on the bottle generally comes long before the drug starts losing effectiveness.”
Backup contraception options
Tydemy is a generic version of a branded oral contraceptive pill, so there could be other generic versions available or patients could even ask for the brand name, depending on insurance coverage, Madden explained.
If patients are concerned about decreased effectiveness, they can use condoms or another method of contraception as a backup while they are waiting to switch to a different birth control pill or to have their Tydemy replaced with an unaffected lot, Madden stated.
“For those who have been taking the recalled lots, I would suggest using backup contraception in addition [to condoms] and then switching to another product or lot,” Berens recommended.
Takeaway
The FDA recently announced that the birth control pill, Tydemy, may have reduced effectiveness as a result of decreased levels of ascorbic acid. Two lots were affected, distributed from June 3, 2022 to May 31, 2023.
Product manufacturer, Lupin Pharmaceuticals recommends patients continue taking their medication and discuss other contraceptive methods with their healthcare provider.
Although there have been no reports of adverse events to date, experts suggest patients use other types of contraception.
Tydemy Birth Control Pills Recalled — FDA Warns 'May Have Reduced Effectiveness'
Source: Pinoy Lang Sakalam
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